3D Printed Models for Mandibular Fracture Repair

Mandible Fracture Clinical Trial

Official title:

Determining the Ease of Utilizing 3D Printed Models to Aide in Isolated Mandibular Fracture Repair

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05733221
• Other study ID #: 2022-0794
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2023
• Est. completion date: April 2024

Study information

• Verified date: February 2023
• Source: University of Cincinnati
• Contact: Deepak G Krishnan, DDS
• Phone: 513-584-2586
• Email: deepak.krishnan[@]uc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators will test the hypothesis that patients randomized to the intervention (3D printing with pre-bent plate) arm have less operative room time and less time for the critical part of the procedure than patients in the control arm (no 3D printing, current standards of care). Personalized medicine and care for fracture treatment.

Description:

The goal of treatment is to re-establish the patient's preinjury dental occlusion and facial harmony. Fractures that are nondisplaced and exhibit no occlusal changes may be amenable to nonsurgical management, but most mandible fractures will require stabilization for satisfactory healing and to restore pretraumatic maxillomandibular orientation. Various treatment strategies have been described and vary widely depending on the fracture location and surgeon's preference. The patient's demographics, comorbidities, dentition, and fracture characterization will all influence the choice of fixation by the treating surgeon. There are very few randomized control trials that show outcomes when 3D printing is used for intervention planning and performing a procedure. These data are essential to establish value of 3D printing as a clinical service. There is also anecdotal evidence that a 3D printed model of a mandible fracture can be useful for pre-operative planning because the oral and maxillofacial surgeon can better assess the geometry of the bone lesions and can pre-bend fixation plates before the procedure. This hypothetically decreases the amount of time in the operating room. The investigators propose a parallel design randomized control trial to study the value of 3D printing for preoperative planning in patients with a fracture of the mandible who require open reduction, internal fixation. The study will be split into two arms: 1) Patients that will have a 3D model generated for the surgical procedure 2) The control group who will follow normal standards of care as outlined above and won't have the additional 3D model created pre-operatively.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Patient = 18 years of age

• Patients who have received either a cone beam or conventional CT
• Admitted through University of Cincinnati Hospital and Medical Center emergency department
• All isolated mandible fractures referred to University of Cincinnati Hospital Oral & maxillofacial surgery clinic
• Surgical team members from the division of plastic and otolaryngology

Exclusion Criteria:

• Patient < 18 years of age
• Patients who have neither cone beam nor conventional CT
• Patients requiring a repeat procedure
• Unexpected exposure of hardware

Related Conditions & MeSH terms

• Fractures, Bone
• Mandible Fracture
• Mandibular Fractures
• Maxillofacial Trauma

Intervention

Device:
• 3D Printed Model
3D Printed Model generated pre-operatively of the patients mandible.

Locations

Country	Name	City	State
United States	UC Health Holmes Hospital	Cincinnati	Ohio
United States	University of Cincinnati Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (25)

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Ravi P, Burch MB, Farahani S, Chepelev LL, Yang D, Ali A, Joyce JR, Lawera N, Stringer J, Morris JM, Ballard DH, Wang KC, Mahoney MC, Kondor S, Rybicki FJ; University of Cincinnati 3D Printing Clinical Service Participants. Utility and Costs During the Initial Year of 3D Printing in an Academic Hospital. J Am Coll Radiol. 2022 Aug 18:S1546-1440(22)00552-X. doi: 10.1016/j.jacr.2022.07.001. Online ahead of print. — View Citation

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total time in the OR	Time in the OR considered critical part of the procedure by the Oral & Maxillofacial Surgery Staff	Total procedural time
Primary	Subjective outcome to surgeon	Surgeon overall satisfaction with utilizing the 3D generated model, obtained via Likert Scale Questions completed post-operatively. The investigators are going to use the Likert questions to develop a numerical scoring system and report that data as "raw" Likert scores. Likert questions and conversion of specialists' responses to Anatomic Model Utility Points (AMUPs). Responses of "strongly disagree", "disagree", and "neutral" were assigned 0 AMUP points. Responses to preprocedural confidence are assigned negative points, to effectively subtract the impact of the anatomic model post- versus pre-procedure. The maximum AMUP for each patient was 500.	Up to 2 days post-procedure